Riociguat for the Treatment of Pulmonary Arterial Hypertension
Riociguat for the Treatment of Pulmonary Arterial Hypertension
复制标题
DOI：
10.1056/nejmoa1209655
复制
发表时间：
2013-07-25
影响因子：
158.5
通讯作者：
Rubin, Lewis J.
中科院分区：
文献类型：
--
作者：
Ghofrani, Hossein-Ardeschir;Galie, Nazzareno;Rubin, Lewis J.
在2期试验中已显示了一种可溶性鸟烯酸酯环化酶刺激剂的BackowstRiociguat，对治疗肺动脉高压的治疗是有益的。该阶段3，双盲研究，我们随机分配了443例有症状的肺动脉高压症患者，riociguat以每天三次的单独调整剂量的2.5 mg（2.5） Mg-Maximum组）或单独调整剂量的riociguat，每天限制为1.5 mg（1.5 mg最大最大组）。为了探索目的，包括1.5 mg最大最大组，该组的数据被描述性分析。未接受其他治疗肺动脉高压疗法的患者和接受内皮素受体拮抗剂或（非肠道）前列腺素的患者符合条件。主要终点是从基线到第12周结束的变化，在6分钟内步行。次要终点包括肺血管抗性的变化，N末端的脑力尿素肽（NT-ProBNP）水平，世界卫生组织（WHO）功能性类别，临床恶化时间，在Borg呼吸困难级别上得分，质量质量， - 寿命变量和安全性。第12周，步行距离的距离平均增加了30 m在安慰剂组中平均降低了6 m（最小二乘平均差异为36 m； 95％置信区间，20至52； p
BACKGROUNDRiociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial to be beneficial in the treatment of pulmonary arterial hypertension.METHODSIn this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted doses of up to 2.5 mg three times daily (2.5 mg-maximum group), or riociguat in individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg-maximum group). The 1.5 mg-maximum group was included for exploratory purposes, and the data from that group were analyzed descriptively. Patients who were receiving no other treatment for pulmonary arterial hypertension and patients who were receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible. The primary end point was the change from baseline to the end of week 12 in the distance walked in 6 minutes. Secondary end points included the change in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, World Health Organization (WHO) functional class, time to clinical worsening, score on the Borg dyspnea scale, quality-of-life variables, and safety.RESULTSBy week 12, the 6-minute walk distance had increased by a mean of 30 m in the 2.5 mg-maximum group and had decreased by a mean of 6 m in the placebo group (least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P